Accelerate your biologic drug development with Praesto®
On September 27th 2018, we officially opened one of the largest agarose-based chromatography resin manufacturing facilities in the world. The site is dedicated solely to the manufacture of our Praesto® mAb purification portfolio and, to date, its construction has boosted local supply chains by £120 million whilst creating and safeguarding over 80 jobs in the UK.
Rt Hon Carwyn Jones AM, First Minister of Wales, and Steve Bates, Chief Executive Officer of the BioIndustry Association, officially opened the state-of-the-art facility with an inauguration ceremony attended by employees, valued partners and customers alike. A great day for all, and a proud moment in the history of Purolite.
Since the very beginning (1981), we have found success by identifying our customers’ pain-points and working smarter, faster and harder than our competitors to deliver the best answer to those problems. As a solutions company, that’s what Purolite has always done, and what we will always continue to do. With that in mind, one year on from the opening ceremony, it’s important to reflect on how the facility has changed us as a company, how it’s affected the market for agarose-based resins, and, most importantly, how our ethos and activities have resonated with our customer base in that time.
The Praesto® line was introduced several years ago, with the overarching goal of supplying higher-performing yet, for the first time, cost-efficient agarose chromatography resins, ultimately reducing the end-user cost of biologics. To aid us in achieving that goal, we needed to go out into the industry and gain as much customer feedback and insight as possible. So that’s what we did. Throughout the course of many conversations with people from all corners of the world, we noticed one issue underpinning several sources of frustration in the market - there was only one viable supplier for process-scale volumes of agarose chromatography resins.
Opening Ceremony, Llantrisant, South Wales, UK (27th September 2018)
Consider then, some of the issues this has created for the Biotech industry in recent decades. Firstly, security of supply. A single supplier means only one source of a key raw material for mAb processing. This is a high risk due to the business critical issue of ensuring uninterrupted supply of the therapeutic treatment to the end user. With the continued growth and therapeutic importance of mAb production, the availability of high-quality agarose resins is critical. Today, approximately 90% of all biopharmaceuticals approved by the U.S. Food and Drug Administration utilize a single source of agarose resins from a single manufacturing site, presenting a security of supply risk to long-term clinical trial material production.
Secondly, as in any industry, competition breeds innovation. A single supplier does not have the same drive or necessity to continually improve their products, as no true competition exists to challenge their standards. This, of course, also applies to improving manufacturing methods and technologies. The primary manufacturing method for agarose resins has remained mostly unchanged since the early 60s, and remains the industry-standard today. In modern bioprocessing, where increasing upstream titres are driving a growing need for higher-performing purification technologies, resin manufacturing limitations will soon create a bottleneck in downstream mAb processing. Manufacturing innovation is crucial today in order to address this issue and 'future-proof' DSP performance. We have addressed this concern directly by developing our own, patented Jetting technology for the production of uniform particle sized agarose resin beads, with a narrow particle size distribution unique to Praesto® resins. This process produces the most advanced agarose base matrix on the market today, with enhanced mass transfer rates, higher capacities and improved lifetime (learn more).
Images (L-R) 1. The view from the tank farm at the facility. 2. Market research conducted by the Medicine Maker, on behalf of Purolite Life Sciences. 3. An agarose vessel in Production Area.
The extensive investment into the Praesto® facility was a major step forward in delivering the industry’s first viable option to address this supply risk. We successfully completed commissioning at the plant in early 2019, including the validation of several Ion Exchange and Protein A resin manufacturing processes. Today, we can comfortably supply a third of global annual demand for agarose-based chromatography resins. The facility is in regular, 7-day production, and serving orders of 1000L+, a proud milestone for the Praesto® team and providing our customers with an increased supplier base and a viable alternative source of this key raw material.
We are proud to have given our customers this option for the first time, and, one year on, we are supplying two of the top ten global CMOs and eight of the world’s largest biopharmaceutical developers.
Congratulations to our Manufacturing team on a fantastic year of production, and here's to another successful year ahead!